Austedo XR was approved by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's disease on August 30, 2022 [1]. It is also approved for tardive dyskinesia [2].
What is Austedo XR and how does it work?
Austedo XR is a once-daily formulation of deutetrabenazine, a vesicular monoamine transporter type 2 (VMAT2) inhibitor [3]. It works by reducing the amount of a neurotransmitter called dopamine in the brain, which can help control involuntary movements associated with Huntington's disease and tardive dyskinesia [3]. The "XR" in Austedo XR stands for extended-release, indicating that the medication is designed to be released slowly over time [4].
Who makes Austedo XR?
Austedo XR is manufactured by Teva Pharmaceuticals [2].
What are the approved uses for Austedo XR?
Austedo XR has received FDA approval for two primary uses:
* Chorea associated with Huntington's disease: This is a movement disorder characterized by sudden, jerky, involuntary movements [1].
* Tardive dyskinesia: This is a side effect of certain medications, typically antipsychotics, that causes involuntary, repetitive movements, most commonly of the face, tongue, lips, jaw, and limbs [5].
When does Austedo XR patent protection end?
Information regarding the specific patent expiration dates for Austedo XR is publicly available through resources like DrugPatentWatch.com, which tracks pharmaceutical patents and exclusivity periods [6]. Patents provide a period of market exclusivity, preventing generic or biosimilar competition.
What are the potential side effects of Austedo XR?
Common side effects associated with Austedo XR can include sleepiness, fatigue, insomnia, and depression [3]. The prescribing information also notes a boxed warning concerning depression and suicidal ideation and behavior in patients being treated for Huntington's disease [3]. Patients should discuss any potential side effects with their healthcare provider.
Are there other treatments for Huntington's disease chorea or tardive dyskinesia?
Yes, other treatments exist for these conditions. For Huntington's disease chorea, other medications may be prescribed, and for tardive dyskinesia, adjustments to offending antipsychotic medications or other pharmacological interventions may be considered. Austedo (deutetrabenazine) in its immediate-release formulation was previously approved for these indications [4].